Device Dossier

Evity 8 HF-T QP - Biventricular pacemaker

Device Dossier for Evity 8 HF-T QP - Biventricular pacemaker (Biventricular pacemaker, Class III, sponsor Biotronik). ARTG record, intended purpose, GMDN…

Intended purpose

Evity is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: •Compensation of bradycardia by atrial, ventricular, or AV sequential pacing •Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacing

Functional description

Evity 8 HF-T QP housing is made of biocompatible titanium, welded from the outside and hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in the case of unipolar lead configuration. Implantable Cardiac Resynchronization Therapy (CRT) Pace Generator; Triple Chamber; Rate Adaptive; unipolar/bipolar; IS4 Compatible; Home Monitoring. ProMRI® labelled , are conditionally safe for use in the MRI environment (MR conditional).

TGA Public Summary